BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    MDR report key: 3162373 · Received June 11, 2013

    Report

    Report Number
    2024168-2013-03640
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    July 10, 2012
    Report Date
    May 23, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    NIQ
    PMA / PMN Number
    P070015
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. (B)(4). THERE WERE NO REPORTED PRODUCT DEFICIENCIES. THE REPORTED PATIENT EFFECTS OF ISCHEMIA AND RESTENOSIS ARE LISTED IN THE (B)(4) PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM INSTRUCTIONS FOR USE (IFU) AS KNOWN PATIENT EFFECTS. IT SHOULD BE NOTED THAT THE IFU (DELIVERY PROCEDURE SECTION) STATES: PRE-DILATE THE LESION WITH A PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY (PTCA) CATHETER. ADDITIONALLY, THE IFU (PURPOSE OF USE SECTION) STATES: THIS DEVICE IS INDICATED FOR IMPROVING CORONARY LUMINAL DIAMETER IN PATIENTS WITH SYMPTOMATIC HEART DISEASE DUE TO DE NOVO (NEW) NATIVE CORONARY ARTERY LESIONS. ALTHOUGH A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECTS AND THE RELATIONSHIP TO THE DEVICE IF ANY CANNOT BE DETERMINED, THERE IS NO INDICATION OF A PRODUCT QUALITY DEFICIENCY WITH RESPECT TO MANUFACTURE, DESIGN, OR LABELING. YOU ARE RECEIVING THIS MDR REPORT FROM ABBOTT VASCULAR BECAUSE BOSTON SCIENTIFIC CORPORATION DISTRIBUTES PROMUS AS ITS OWN BRAND LABELING OF ABBOTT VASCULARS DRUG ELUTING STENT IN THE US.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT ON (B)64) 2011, THE PATIENT UNDERWENT STENTING IN THE PROXIMAL LEFT ANTERIOR DESCENDING CORONARY ARTERY (LAD) WITH ONE PROMUS STENT. ON (B)(6) 2012, THE PATIENT HAD SILENT ISCHEMIA. ON (B)(6) 2012, PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED TO TREAT RESTENOSIS IN THE TARGET LESION. THE CONDITION RESOLVED ON (B)(6) 2012. THE PATIENT WAS IN THE HOSPITAL FOR THREE DAYS. THERE WERE NO ADVERSE PATIENT SEQUELAE. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    261843 PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM DRUG ELUTING CORONARY STENT SYSTEM NIQ AV-TEMECULA-CT 9121041

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Hospitalization| R ASPIRIN, CLOPIDOGREL